Actively Recruiting
Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis
Led by The University of Texas Health Science Center, Houston · Updated on 2026-03-09
58
Participants Needed
1
Research Sites
380 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.
CONDITIONS
Official Title
Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult 18 years of age or older
- History of active ulcerative colitis in the past 12 months based on clinical, endoscopic, or histologic criteria
- Currently in remission with partial Mayo score of 2 or less and each subscore 1 or less on stable maintenance therapy
- Sexually active males and females of childbearing potential agree to use effective birth control during the study
- Female participants of childbearing potential have a negative urine pregnancy test at enrollment and on Week 1, Day 1 prior to treatment
- Willing and able to sign informed consent and attend all study visits and follow-ups
- Has an attending physician providing non-FMT care
You will not qualify if you...
- Unable to take multiple capsules orally
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- Received systemic non-topical antibiotics within 14 days before treatment start
- Positive for active HIV, Hepatitis B, or Hepatitis C infections
- History of recurrent Clostridium difficile infection or fecal microbiota transplantation in past 6 months
- History of other active gastrointestinal conditions like irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, fistulae, strictures, chronic parasitic infections, diverticulitis
- Known history of bile acid diarrhea
- Compromised immune system or immunosuppression due to medical condition or medication (e.g., prednisone over 20 mg daily)
- History of active cancer or ongoing chemotherapy (except superficial non-metastatic or maintenance chemotherapy)
- Use of investigational drug within 90 days before screening
- Significant uncontrolled systemic disease interfering with participation
- Life expectancy less than 1 year
- Any other reason investigator deems exclusion necessary
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Herbert DuPont, md
CONTACT
Z
Zhi-Dong Jiang, Dr.PH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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